Cell and gene therapies represent a promising opportunity to address unmet medical needs in several fields of medicine today. In fact, several products have been recently approved, but only after rigorous demonstration of their risk-benefit profile with documented benefits. Many more are currently undergoing clinical trials in order to generate adequate information that supports their future use, once approved by regulatory authorities, for the proper benefit of patients. However, despite these legitimate attempts to provide valid new therapies, a number of organizations persist in exploiting the hope of patients in difficult situations by providing unproven and dangerous stem cell therapies.

“It is encouraging that the FTC has taken this action to protect vulnerable patients from predatory and unethical practices by unscrupulous organizations. Validated cell therapies must be grounded in science and clinical development subject to peer review and appropriate regulatory oversight.”, said Bruce Levine, Co-Chair of the ISCT Global Government and Public Relations Committee.

“The mission of ISCT is to promote access to innovative, evidence-supported cell and gene therapies to patients. Bringing new treatments to the market is still a pioneering field with tremendous implications, especially for those conditions with few current approved effective treatments. However, this has led some clinics to offer procedures with, at best, questionable clinical benefits, and at worst, terrible consequences for patients,” said Massimo Dominici, Chair of the ISCT Presidential Task Force (PTF) on the Use of Unproven/Unethical Cell & Gene Therapies.

The ISCT, for the sake of patient safety, has fought unproven/unethical cell and gene therapies via the ISCT PTF on the Use of Unproven/Unethical Cell & Gene Therapies. ISCT continues to support the legitimate uses of new therapies in a safe, regulated manner, and supports the action of the FTC to protect patients.